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FDA 510(k)

SKELITE RESORBABLE CEMENT RESTRICTOR

K-Number: K051836 · 2005-11-21

ApplicantMillenium Biologix, Inc.
Decision Date2005-11-21
Product CodeJDK
Advisory CommitteeSU
DecisionUnknown

Device Summary

SKELITE RESORBABLE CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Millenium Biologix, Inc.. It received FDA 510(k) clearance on 2005-11-21 under 510(k) number K051836. The device is classified under product code JDK. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the SKELITE RESORBABLE CEMENT RESTRICTOR?

SKELITE RESORBABLE CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 2005-11-21. The listed applicant is Millenium Biologix, Inc.. The 510(k) number is K051836.

When did SKELITE RESORBABLE CEMENT RESTRICTOR receive FDA 510(k) clearance?

SKELITE RESORBABLE CEMENT RESTRICTOR received FDA 510(k) clearance on 2005-11-21, under 510(k) number K051836.

Who is the listed applicant for SKELITE RESORBABLE CEMENT RESTRICTOR?

The FDA 510(k) record lists Millenium Biologix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKELITE RESORBABLE CEMENT RESTRICTOR?

The FDA product code for SKELITE RESORBABLE CEMENT RESTRICTOR is JDK.

Related Clinical Trials

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Other records listing Millenium Biologix, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K011726MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER

Related Devices (Code: JDK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210062Mectaplug PE IIMedacta International S.A.K061465KMI CEMENT RESTRICTOR IMPLANTKinetikos Medical, Inc.K061698MODIFICATION TO LIFE SPINE CEMENT RESTRICTORLife SpineK060247LIFE SPINE CEMENT RESTRICTORLife SpineK060132SPINAL USA CEMENT RESTRICTOR SYSTEMSpinal USAK051371INTERBODY INNOVATIONS CEMENT RESTRICTORInterbody Innovations, Llp

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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